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Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma (GOTEL-FL1LC)

Primary Purpose

Follicular Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Y90 Ibritumomab Tiuxetan
Sponsored by
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
  • Patients older than 18.
  • Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
  • High-risk patients according to FLIPI before initiation of induction chemotherapy.
  • Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
  • Complete or partial response to the induction scheme.
  • ECOG scale performance status 0 - 2.
  • Life expectancy greater than 3 months.
  • In women of childbearing age, use of a reliable contraceptive method.

  • A suitable bone marrow reserve:

    • Lower than 25% Bone marrow infiltration by lymphoma.
    • Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3

    • Suitable hepatic, renal and cardiac function:

      • creatinine <2,5 x UNL (upper normality limit).
      • bilirubin or ALT/AST < 2,5 x UNL

Exclusion Criteria:

  • Patients with no objective clinical response to induction chemotherapy.
  • > 25% bone marrow infiltration following induction chemotherapy.
  • Platelets < 100,000 before radioimmunotherapy.
  • Severe and/or uncontrolled concomitant disease:
  • Hepatic, renal, cardiovascular, neurological or metabolic disease.
  • Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
  • Positive regarding HBV, HCV, HIV.
  • Active acute or chronic infection.
  • Social, psychic or geographic disability to satisfy any of the treatment schemes.
  • Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
  • Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).

Sites / Locations

  • Hospital Virgen de la Victoria
  • Instituto Oncológico San Sebastián
  • Hospital Universitario de Canarias
  • Hospital Sant Joan de Reus
  • Hospital Virgen de las Nieves
  • Clinia Puerta de HierroRecruiting
  • Clínica Ruber Internacional
  • Complejo Hospitalario de Pontevedra
  • Hospital Universitario Virgen Macarena
  • Hospital Virgen de la Salud de Toledo
  • Hospital Universitario La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1. Consolidation with Y90 Ibritumomab Tiuxetan

Arm Description

1. Consolidation with Y90 Ibritumomab Tiuxetan

Outcomes

Primary Outcome Measures

CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease

Secondary Outcome Measures

Objective clinical response rate (complete + partial).
Response conversion rate
Incidence of complete molecular responses
Response duration
Event-free survival.
Progression-free survival
Time to salvage therapy
Lymphoma-free or specific cause-free survival
Overall survival
Toxicity profile and safety of the consolidation

Full Information

First Posted
July 25, 2008
Last Updated
July 25, 2008
Sponsor
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
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1. Study Identification

Unique Protocol Identification Number
NCT00722930
Brief Title
Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma
Acronym
GOTEL-FL1LC
Official Title
Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Consolidation with Y90 Ibritumomab Tiuxetan
Arm Type
Experimental
Arm Description
1. Consolidation with Y90 Ibritumomab Tiuxetan
Intervention Type
Drug
Intervention Name(s)
Y90 Ibritumomab Tiuxetan
Intervention Description
Consolidation with Y90 Ibritumomab Tiuxetan
Primary Outcome Measure Information:
Title
CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease
Time Frame
12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter
Secondary Outcome Measure Information:
Title
Objective clinical response rate (complete + partial).
Time Frame
3 months
Title
Response conversion rate
Time Frame
3 months
Title
Incidence of complete molecular responses
Time Frame
3 months
Title
Response duration
Time Frame
36 months
Title
Event-free survival.
Time Frame
36 months
Title
Progression-free survival
Time Frame
36 months
Title
Time to salvage therapy
Time Frame
36 months
Title
Lymphoma-free or specific cause-free survival
Time Frame
36 months
Title
Overall survival
Time Frame
60 months
Title
Toxicity profile and safety of the consolidation
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure. Patients older than 18. Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification. High-risk patients according to FLIPI before initiation of induction chemotherapy. Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma. Complete or partial response to the induction scheme. ECOG scale performance status 0 - 2. Life expectancy greater than 3 months. In women of childbearing age, use of a reliable contraceptive method. A suitable bone marrow reserve: Lower than 25% Bone marrow infiltration by lymphoma. Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3 Suitable hepatic, renal and cardiac function: creatinine <2,5 x UNL (upper normality limit). bilirubin or ALT/AST < 2,5 x UNL Exclusion Criteria: Patients with no objective clinical response to induction chemotherapy. > 25% bone marrow infiltration following induction chemotherapy. Platelets < 100,000 before radioimmunotherapy. Severe and/or uncontrolled concomitant disease: Hepatic, renal, cardiovascular, neurological or metabolic disease. Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia. Positive regarding HBV, HCV, HIV. Active acute or chronic infection. Social, psychic or geographic disability to satisfy any of the treatment schemes. Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter. Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano Provencio, MD
Phone
+34-91-344-57-60
Email
mprovenciop@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Cerdeira, Secretary
Phone
34 91 3445131
Email
secretariatecnica@grupolinfomas.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Provencio, MD
Organizational Affiliation
Clínica Puerta de Hierro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen de la Victoria
City
Málaga
State/Province
Malaga
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Instituto Oncológico San Sebastián
City
Donostia
State/Province
San Sebastián
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz de Tenerife
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinia Puerta de Hierro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Provencio, MD
Facility Name
Clínica Ruber Internacional
City
Madrid
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Virgen de la Salud de Toledo
City
Toledo
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma

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